Duns Number:419980156
Device Description: Tooth Brush, Manual
Catalog Number
HA090
Brand Name
Cavex RushBrush
Version/Model Number
HA090
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFW
Product Code Name
Toothbrush, Manual
Public Device Record Key
a978b48d-a4df-4ae7-b26b-b89235de5997
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
July 07, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 33 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |